FDA Label for Spot On Treatment
View Indications, Usage & Precautions
Spot On Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Sgii, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Benzoyl Peroxide 10%
Purpose
Acne Treatment
Uses
For the treatment of Acne
Warnings
For External Use Only
Keep Out Of Eyes
Otc - When Using
When using this product • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
Otc - Do Not Use
Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide
Otc - Stop Use
Stop use and ask a doctor if • irritation becomes severe.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•Clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three
times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredients
Aqua/Water/Eau, Aloe Vera (Aloe Barbadensis) Leaf Juice, Dimethyl Isosorbide, Polyacrylamide, C13-14 Isoparaffin, Menthoxypropanediol, Laureth-7, Phenoxyethanol, Propanediol, Sodium Citrate, Allantoin, Bisabolol, Caprylyl Glycol, Diethylhexyl Sodium Sulfosuccinate, Panthenol, Carbomer, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Ginger (Zingiber Officinale) Root Extract
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